How to apply for a Shenzhen medical device business license? What information is required?

国家食品药品监管总局发布2025年第112号公告，决定对医疗器械流通领域违法经营行为开展集中整治。

announcement

Require

所有从事第二类、第三类医疗器械经营企业对本企业2014年6月1日以来的医疗器械经营行为是否存在8个方面的违法问题开展自查，对存在的问题详细描述所用手法、go through、Involving medical equipment and personnel，Carefully formulate corrective measures and plans，Form a self-examination and rectification report，于2025年7月15日前报送所在地设区的市级食品药品监管部门。

总局公告发布后，合肥市食品药品监管局迅速行动，在本局官网对总局公告进行转发，并通过医疗器械经营企业QQ群告知企业。办理人力资源许可证的条件和流程?深圳专业代办人力资源经营许可证，欢迎有需要的您来电咨询业务。人力资源许可证怎么办理?多年专业领域的成长，提供给你高品质的保证。

咨询顾问港信通-行政许可内容：

1. Review and issue the newly issued "Medical Device Business Enterprise License"(second、Class III medical devices)
2. Category 2、Class III medical device business enterprise merger、Legal basis for establishment of permission for division or transfer across original jurisdictions：
3. "Regulations on the Supervision and Administration of Medical Devices";
4. "Measures for the Administration of Licenses for Medical Device Business Enterprises" Specific Matters on Administrative Licensing Conditions：
5. Legal representative of the enterprise、Business person in charge、Quality management personnel should not have the circumstances specified in Article 40 of the "Regulations on the Supervision and Administration of Medical Devices";
6. The enterprise should have a quality management organization or full-time quality management personnel that is commensurate with its business scale and scope.;Quality management personnel should have relevant professional academic qualifications or professional titles recognized by the state，Professional and technical personnel who have been qualified in accordance with the law。

For example, the quality manager should be on-the-job，Not allowed to work part-time in other units

1. Have a relatively independent business location that is commensurate with the business scale and scope of business。
2. Have storage conditions suitable for the business scale and business scope(storage device、facility)。
3. Have technical training on operating products、After-sales service capabilities。
4. Should be based on relevant national and local regulations，Establish and improve the necessary quality management system，and strictly enforce。
5. National standards for medical devices should be collected and preserved、Industry standards and regulations on medical device supervision and management、Regulations and special provisions。
6. Passed the acceptance inspection in accordance with the "Implementation Standards for the Acceptance of Medical Device Business Enterprises in Guangdong Province"。申请人提交材料目录：Data number
7. "Medical Device Business Enterprise License Application Form"，"Medical Device Business Enterprise License"。

Data number

1. "Notice of Pre-approval of Enterprise Name" or "Industrial and Commercial Business License" issued by the industrial and commercial administration department。Data number
2. Application report。Data number
3. Business premises、Documentation proving the warehouse location，Include a copy of the property certificate or lease agreement and the lessor’s property certificate。Data number
4. Business premises、Warehouse layout plan。

Data number

1. Person in charge of formulating the law、Business person in charge、Quality manager’s ID card、Copy of academic certificate or professional title certificate and resume。Data number
2. List and academic qualifications of technical personnel、Copy of professional title certificate。Data number
3. Business quality management specification document directory。Data number
4. Enterprise installed product purchases、pin、stored information management system，Print the home page of the information management system。Data number
5. Warehousing Facility Equipment Catalog。

Data number

1. Quality management personnel’s on-the-job self-assurance statement and self-assurance statement on the authenticity of application materials，Including the catalog of application materials and the company's commitment to bear legal responsibility if the materials are false.;Data number
2. When applying for enterprise declaration materials，The person handling the matter is not the legal representative or person in charge himself，The enterprise should submit a "Power of Attorney"。

Data No. 13、Application for "Medical Device Business Enterprise License" confirmation letter for application materials

Require

：

1. The "Medical Device Business Enterprise License Application Form" submitted by the operating enterprise should be signed by the legal representative or stamped with the official seal of the enterprise.;
2. The items filled in the "Medical Device Business Enterprise License Application Form" should be filled in completely、precise，The content to be filled in should comply with the following

Require

。

A、"Company name"、The "registered address" is the same as the "Industrial and Commercial Business License" or "Notice of Pre-Approval of Enterprise Name"。B、The business scope to be applied for shall be filled in according to the first-level catalog of the "Medical Device Classification Catalog" issued by the State Food and Drug Administration in 2002.。C、"Registered Address"、When filling in the "warehouse address", the specific house number should be clearly stated.、Floor and room number。

1. Proof of identity of legal representative、Certificate of academic qualifications and professional title、The appointment document should be valid;
2. The copy of the "Notice of Pre-approval of Enterprise Name" or "Industrial and Commercial Business License" issued by the industrial and commercial administration department should be the same as the original，Copy to confirm and keep，Originals returned;
3. Property certificate、House rental certificate(The lessor must provide proof of property ownership)should be valid;
4. Business person in charge、Quality manager resume、Educational qualification certificate or professional title certificate should be valid;
5. Enterprises should establish medical device quality management files or forms based on their own actual conditions。
6. The self-guarantee statement on the authenticity of the application materials should be signed by the legal representative and stamped with the official seal of the company.，If there is no official seal，The signature or seal of the legal representative must be。
7. All application materials need to be submitted with copies，applicant(unit)The copy must be marked with the words "This copy is consistent with the original" or a text description，Date，Stamped with the official seal of the unit;Individual applications must be signed or stamped。
8. Application materials should be complete、clear、signature，And stamp each copy with the official seal，All application forms are typed and filled out by computer，Print on A4 paper，Use A4 paper for copying，Bind into a volume according to the order of the application materials catalog。

legal liability：

1. The applicant conceals relevant information or provides false materials to apply for the "Medical Device Business Enterprise License"，Province、autonomous region、municipality(food)The drug regulatory department or the districted municipality that accepts the entrustment(food)The drug regulatory agency will not accept the application or issue a "Medical Device Business Enterprise License"，and give warning。The applicant shall not apply for the "Medical Device Business Enterprise License" again within 1 year.。
2. The applicant deceived、Obtaining the "Medical Device Business Enterprise License" by improper means such as bribery，(food)The drug regulatory department should revoke its "Medical Device Business Enterprise License"，give warning，and a fine of not less than 10,000 yuan but not more than 20,000 yuan。The applicant shall not apply for the "Medical Device Business Enterprise License" again within 3 years.。

深圳商务有限公司咨询顾问港信通-地址：Related news：合肥市局将于近期加大医疗器械经营企业的检查力度，对到期未按

Require

报告的企业，向社会公开企业名单，Listed as key inspection objects;Refusal to report、谎报瞒报以及自查不认真、Inadequate rectification，从严从重查处，直至吊销“医疗器械经营许可证”。

合肥市局一直将医疗器械流通领域尤其是第三类医疗器械批发企业作为监管的重点，始终保持高压态势。this year，已对20家存在擅自变更经营场所或库房地址等违法行为的企业移交稽查部门处理。并有26家难以满足经营规范

Require

的企业申请注销“医疗器械经营许可证”。

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